This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:

TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.

FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.

Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:

10 year Disease-free survival (DFS)

Secondary Outcome Measures:

10 year Overall survival (OS)

Toxicity

Quality of life

Biological markers

Estimated Enrollment:

1054

Study Start Date:

June 1999

Estimated Study Completion Date:

June 2005

Detailed Description:

Primary objective:

To compare disease-free survival (DFS) after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes.

Secondary objectives:

To compare overall survival (OS) between the 2 above mentioned arms.

To compare toxicity and quality of life between the 2 above mentioned arms.

Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.

Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.

Patients without proven metastatic disease.

Estrogen and progesterone receptors performed on the primary tumour prior to randomization.

Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.

Concurrent treatment with any other anti-cancer therapy.

Male patients.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121992